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The University of Southampton
Medicine

Research project: CERAbTc-19 (Clinical Evaluation of Rapid Antibody Test for Covid-19)

Currently Active: 
Yes

Rapid, accurate diagnosis of Covid-19 would greatly help to improve clinical management of patients presenting with symptoms of possible Covid-19. Currently results of the standard test for the virus take 2-3 days to be reported.

The results of this study are now available as a pre-print, you can view by clicking here.

Watford General Hospital has imported rapid antibody tests manufactured by Zuhai Livzon Diagnostics Inc in China and our team aims to evaluate their accuracy and clinical usefulness. The test involves taking a drop of blood from the patient (either from a venous blood sample taken for other blood tests, or from a fingerprick). This is applied to a test strip (similar to a pregnancy test) and two drops of diluent are added. If the patient has antibodies to Covid-19, two lines appear on the test strip (like a positive pregnancy test) whereas if the patient has no antibodies, only one line appears (like a negative pregnancy test). There are two different types of antibody: IgM is produced early in the course of the illness (day 7-14) and then IgG is produced later and continues to be present, probably for months or years. There are two test strips, one for each of these types of antibody. 

In this study we aim to evaluate the accuracy of this new test, in patients with proven Covid-19 and at least 7 days after the onset of their illness. We aim to recruit 200 patients in total: at least 138 patients with 10 or more days of symptoms, plus a subgroup of up to 62 patients with 7-9 days of symptoms (to explore the usefulness of the test earlier in the course of illness). As we are not sure of the accuracy of the new test, its results will not be used to make decisions about treatment for the patient.

This study will enable us to discover rapidly whether the new test is accurate, and if so we will conduct further studies to assess how it can help to improve management of patients with suspected Covid-19.

University of Southampton Investigators:

Professor Michael Moore (Chief Investigator)
Co-investigators:
Dr Rama Vancheeswaran, West Hertfordshire Hospitals NHS Trust
Dr Matthew Knight, West Hertfordshire Hospitals NHS Trust
Dr Hala Kandil, West Hertfordshire Hospitals NHS Trust
Dr Andrew Barlow, West Hertfordshire Hospitals NHS Trust


Funder: This Study is not externally funded. The cost of the rapid antibody tests will be funded by West Hertfordshire Hospitals NHS Trust. Clinicians recruiting patients will do this alongside their clinical duties with no extra payments.  SCTU core funding (NIHR) will cover the involvement of the study manager and statistician.

Duration: 3 months    

Start date: 16 May 2020 - End date 31 July 2020

Contact: M.L.Willcox@soton.ac.uk

Related research groups

Primary Care, Population Sciences and Medical Education
Primary Care Research Centre
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